Drug Shortages: New Bill Proposed

Senator Amy Klobuchar (D-MN) hosted a panel discussion on access and affordability of prescription medications in January. Drug shortages have tripled since 2005, affecting the public’s access to critical medications. The shortages have affected many components of parenteral nutrition (PN) solutions, including trace elements and vitamins. Shortages can be influenced by a lack of raw materials, financial decisions by pharmaceutical companies, and regulatory barriers which slow production but don’t improve product safety.

The panel also addressed affordability. All too frequently, brand name drug manufacturers will pay significant sums to generic drug manufacturers to delay availability of less expensive options. This is expected to increase the cost of Medicare by as much as $2.6 billion over the next ten years. This practice is considered to be a violation of federal antitrust law. Chairman of the Federal Trade Commission, Jon Liebowitz, participated on the panel and called this the "most abusive practice in health care today.” These "pay for delay” arrangements can further aggravate overall drug shortages and affordability of needed medication, according to Stephen Schondelmeyer, an expert in pharmaceutical economics and another member of the panel.

Also in January, U.S. Representatives John Carney (D-DE) and Larry Bucshon (R-IN) introduced "The Drug Shortage Prevention Act.” This new bill (HR 3839) mandates expedited review of drugs vulnerable to shortage in order to prevent shortages in the first place and it requires the FDA to use a more refined regulatory process that addresses manufacturing problems without instigating drug shortages. The American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) is endorsing this bill.

Senator Klobuchar has also sponsored federal legislation—S. 296, "Preserving Access to Life-Saving Medications”—to address the issues of access and affordability. This past year she helped move S. 296 through the Senate Judiciary Committee. The legislation continues to move through the Senate. You may have already read about this bill—and its companion bill, HR 2245, "Preserving Access to Life-Saving Medications Act of 2011”—in this newsletter.

It’s also worth noting that in October, President Obama issued an executive order aimed at resolving the growing number of shortages. This action is an acknowledgment that the administration is taking drug shortages seriously.

What can you do? Contact your U.S. Senators and Representatives to let them know the importance of these bills to your health and survival. (Click here for Sample letter.) In the past two years, every component of HPN, except water, has been in short supply, and each component is absolutely essential for the maintenance of your health and your survival. Also, ask your home infusion companies to let their other clients know that this approach might impact the effectiveness of this legislation. Together we can really make a difference with this issue.

—Mary Patnode, with Oley staff

Editor’s note: To read detailed information about the current legislation and how the shortages are affecting consumers, click here.

This website is an educational resource. It is not intended to provide medical advice or recommend a course of treatment. You should discuss all issues, ideas, suggestions, etc. with your clinician prior to use. Clinicians in a relevant field have reviewed the medical information; however, the Oley Foundation does not guarantee the accuracy of the information presented, and is not liable if information is incorrect or incomplete. If you have questions please contact Oley staff.

Updated in 2015 with a generous grant from Shire, Inc.

This website was updated in 2015 with a generous grant from Shire, Inc. This website is an educational resource. It is not intended to provide medical advice or recommend a course of treatment. You should discuss all issues, ideas, suggestions, etc. with your clinician prior to use. Clinicians in a relevant field have reviewed the medical information; however, the Oley Foundation does not guarantee the accuracy of the information presented, and is not liable if information is incorrect or incomplete. If you have questions please contact Oley staff.